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NCT Number: NCT07245420

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

Childhood cancer survivors who received certain treatments are at a higher risk of developing heart problems in the future. This study is looking at ways to educate childhood cancer survivors about that risk and encourage them to receive a recommended heart screening test.

Recruiting

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Key information

Age range

26 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Matthew Ehrhardt, MD, MS, MPI

CONTACT

[email protected]

888-226-4343

Matthew Ehrhardt, MD, MS, MPI

PRINCIPAL_INVESTIGATOR

About this study

Primary Objective:

  • To determine the efficacy of the Healthy Hearts eHealth intervention compared to standard of care for improving screening echocardiogram adherence in childhood cancer survivors.

Secondary Objective

  • To determine the efficacy of the Healthy Hearts eHealth intervention compared to standard of care for improving mediators of screening echocardiogram adherence in childhood cancer survivors.

After consenting, participants will complete a survey that will take about 15-20 minutes to complete. After this survey, they will be randomly assigned to participate in the Healthy Hearts eHealth Intervention or to receive standard educational materials about hearth health screening.

All participants will receive the Standard of Care (SOC) materials delivered via the Computerized Intervention Authoring System (CIAS) platform (i.e., a personalized survivorship care plan and educational materials regarding cardiomyopathy risk and need for screening). In addition to the SOC materials received by controls, the Healthy Hearts eHealth intervention arm will receive CIAS platform delivered Motivational Interview (MI), including scripted interaction with an avatar, video vignettes, and patient testimonials

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Childhood Cancer Survivor Study (CCSS) Participants
  • Age ≥26 years
  • Treated with cumulative doxorubicin equivalent anthracycline doses ≥100 mg/m2 with any/no radiation, or ≥15 Gy chest radiation with any/no anthracyclines
  • No history of cardiomyopathy
  • Has not had an echocardiogram in the previous 5 years
  • Has a history of successful completion of CCSS surveys
  • English-Speaking
  • Has not been enrolled in ECHOS-1 (pilot)

Exclusion criteria

  • Currently participating in a long-term follow-up program that provides risk-based screening

Treatment and study plan

Survivorship Care Plan + Educational Materials (delivered via CIAS platform)

Behavioral

Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations. Materials are delivered via the CIAS platform and include infographics, treatment summaries, and general information about screening.

Healthy Hearts eHealth Program

Behavioral

Participants receive the same SOC materials plus a tailored, interactive eHealth intervention delivered via the CIAS platform. This includes avatar-led motivational interviewing (MI), survivor video vignettes, interactive modules addressing perceived barriers, self-efficacy, and goal setting. The intervention is designed to mimic MI counseling in a scalable format.

Primary outcomes

  1. Number of Participants who Received Cardiomyopathy Screening at 12 months between Participants Randomized to the Healthy Hearts eHealth Intervention group as compared to the standard of care.

    Time frame: 12 months

    This outcome will be measured through self-reported questionnaire at 12 months along with confirmation through medical record review.

  2. Difference in Precursors to Cardiomyopathy Screening at 12 months between Participants Randomized to the Healthy Hearts eHealth Intervention group as Compared to the Standard of Care.

    Time frame: 12 months

    This outcome will use questions included in the baseline and 12 month questionnaire to calculate the differences in precursors to cardiomyopathy screening (perceived barriers, knowledge, motivation, beliefs, self-efficacy) at 12 months between participants randomized to Healthy Hearts eHealth Intervention vs participants assigned to standard care.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Ehrhardt, MD, MS, MPI

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Nov 24, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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